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    Clinical Trial Results:
    Single Dose, Open Label Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Evaluation of Three Different Eplivanserin Doses in Children Aged 6-17 Years With Insomnia of Various Origins

    Summary
    EudraCT number
    2014-004644-35
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    29 Dec 2009

    Results information
    Results version number
    v1(current)
    This version publication date
    13 Apr 2016
    First version publication date
    06 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    PKD10491
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00913614
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi U.S Services Inc.
    Sponsor organisation address
    55 Corporate Drive Bridgewater, New Jersey, United States, 08807
    Public contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi aventis recherche & développement, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000114-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    29 Jan 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Dec 2009
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    There are 2 primary objectives in this trial: To assess the safety and tolerability after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins. To assess the pharmacokinetics of eplivanserin (and active metabolite: SR141342) after administration of single ascending oral doses of eplivanserin to children aged 6-17 years with insomnia of various origins.
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 May 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    21
    Adolescents (12-17 years)
    20
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 10 sites in the United States of America. A total of 41 subjects were enrolled between 11 May 2009 and 10 December 2009.

    Pre-assignment
    Screening details
    All 41 enrolled subjects were treated.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Eplivanserin 0.01 mg/kg: 6-11 years
    Arm description
    Single dose of Eplivanserin on day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Eplivanserin
    Investigational medicinal product code
    SR46349
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eplivanserin 0.01 mg/kg before the subjects’ normal bedtime.

    Arm title
    Eplivanserin 0.035 mg/kg: 6-11 years
    Arm description
    Single dose of Eplivanserin on day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Eplivanserin
    Investigational medicinal product code
    SR46349
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eplivanserin 0.035 mg/kg before the subjects’ normal bedtime.

    Arm title
    Eplivanserin 0.07 mg/kg: 6-11 years
    Arm description
    Single dose of Eplivanserin on day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Eplivanserin
    Investigational medicinal product code
    SR46349
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eplivanserin 0.07 mg/kg before the subjects’ normal bedtime.

    Arm title
    Eplivanserin 0.01 mg/kg: 12-17 years
    Arm description
    Single dose of Eplivanserin on day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Eplivanserin
    Investigational medicinal product code
    SR46349
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eplivanserin 0.01 mg/kg before the subjects’ normal bedtime.

    Arm title
    Eplivanserin 0.035 mg/kg: 12-17 years
    Arm description
    Single dose of Eplivanserin on day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Eplivanserin
    Investigational medicinal product code
    SR46349
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eplivanserin 0.035 mg/kg before the subjects’ normal bedtime.

    Arm title
    Eplivanserin 0.07 mg/kg: 12-17 years
    Arm description
    Single dose of Eplivanserin on day 1.
    Arm type
    Experimental

    Investigational medicinal product name
    Eplivanserin
    Investigational medicinal product code
    SR46349
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Eplivanserin 0.07 mg/kg before the subjects’ normal bedtime.

    Number of subjects in period 1
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.07 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years Eplivanserin 0.07 mg/kg: 12-17 years
    Started
    7
    7
    7
    7
    7
    6
    Treated
    7
    7
    7
    7
    7
    6
    Completed
    7
    7
    6
    7
    7
    6
    Not completed
    0
    0
    1
    0
    0
    0
         Lost to follow-up
    -
    -
    1
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eplivanserin 0.01 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.035 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.07 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.01 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.035 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.07 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group values
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.07 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years Eplivanserin 0.07 mg/kg: 12-17 years Total
    Number of subjects
    7 7 7 7 7 6 41
    Age categorical
    Units: Subjects
        Children (2-11 years)
    7 7 7 0 0 0 21
        Adolescents (12-17 years)
    0 0 0 7 7 6 20
    Gender categorical
    Units: Subjects
        Female
    3 2 3 2 3 4 17
        Male
    4 5 4 5 4 2 24

    End points

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    End points reporting groups
    Reporting group title
    Eplivanserin 0.01 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.035 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.07 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.01 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.035 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.07 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Primary: Pharmacokinetic (PK) Parameters: Area Under Curve (AUC 0-24) of Eplivanserin and SR141342

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    End point title
    Pharmacokinetic (PK) Parameters: Area Under Curve (AUC 0-24) of Eplivanserin and SR141342 [1] [2]
    End point description
    Analysis was performed on Pharmacokinetic population which included all subjects with no major deviations related to study drug intake, for whom the primary pharmacokinetic data was considered sufficient and interpretable.
    End point type
    Primary
    End point timeframe
    1, 3, 6, 24 hours post-dose on Day 1
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The purpose was to provide descriptive statistics only.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis of PK focused only on 0.01 and 0.035 mg/kg/day of eplivanserin in children 6 to 11 and 12 to 17 years of age.
    End point values
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years
    Number of subjects analysed
    7
    7
    7
    7
    Units: ng*h/mL
    arithmetic mean (standard deviation)
        Eplivanserin AUC 0-24
    7.69 ± 2.14
    33.5 ± 3.95
    9.28 ± 2.24
    47.8 ± 16.1
        SR141342 AUC 0-24
    1.52 ± 0.578
    7.55 ± 1.81
    1.71 ± 0.495
    7.39 ± 2.16
    No statistical analyses for this end point

    Primary: Maximum plasma concentration (Cmax) of Eplivanserin and SR141342

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    End point title
    Maximum plasma concentration (Cmax) of Eplivanserin and SR141342 [3] [4]
    End point description
    Analysis was performed on pharmacokinetic population.
    End point type
    Primary
    End point timeframe
    1, 3, 6, 24 hours post-dose on Day 1
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The purpose was to provide descriptive statistics only.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Statistical analysis of PK focused only on 0.01 and 0.035 mg/kg/day of eplivanserin in children 6 to 11 and 12 to 17 years of age.
    End point values
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years
    Number of subjects analysed
    7
    7
    7
    7
    Units: ng/mL
    arithmetic mean (standard deviation)
        Eplivanserin: Cmax
    0.582 ± 0.202
    2.25 ± 0.337
    0.666 ± 0.181
    2.98 ± 0.745
        SR141342: Cmax
    0.0852 ± 0.0215
    0.422 ± 0.0832
    0.0891 ± 0.0248
    0.412 ± 0.122
    No statistical analyses for this end point

    Primary: Overview of Treatment-Emergent Adverse Events (TEAE)

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    End point title
    Overview of Treatment-Emergent Adverse Events (TEAE) [5]
    End point description
    Analysis was performed on safety population defined as all randomized and treated population regardless of the amount of treatment administered.
    End point type
    Primary
    End point timeframe
    Baseline up to end of the study (Day 17 - 20)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The purpose was to provide descriptive statistics only.
    End point values
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.07 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years Eplivanserin 0.07 mg/kg: 12-17 years
    Number of subjects analysed
    7
    7
    7
    7
    7
    6
    Units: subjects
        Any TEAE
    3
    1
    3
    2
    4
    3
        Any severe TEAE
    0
    0
    0
    0
    0
    0
        Any serious TEAE
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Global Sleep Parameters

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    End point title
    Global Sleep Parameters
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately following single dose administration
    End point values
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.07 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years Eplivanserin 0.07 mg/kg: 12-17 years
    Number of subjects analysed
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    0 [10]
    0 [11]
    Units: not analysed
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Notes
    [6] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [7] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [8] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [9] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [10] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [11] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    No statistical analyses for this end point

    Secondary: Sleep Architecture

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    End point title
    Sleep Architecture
    End point description
    End point type
    Secondary
    End point timeframe
    Immediately following single dose administration
    End point values
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.07 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years Eplivanserin 0.07 mg/kg: 12-17 years
    Number of subjects analysed
    0 [12]
    0 [13]
    0 [14]
    0 [15]
    0 [16]
    0 [17]
    Units: not analysed
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    Notes
    [12] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [13] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [14] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [15] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [16] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    [17] - The study was prematurely discontinued, hence no statistical analysis have been performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Day 17-20) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported adverse events are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (from the time of study drug administration up to the end of study visit [included]).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Eplivanserin 0.01 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.035 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.07 mg/kg: 6-11 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.01 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.035 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Reporting group title
    Eplivanserin 0.07 mg/kg: 12-17 years
    Reporting group description
    Single dose of Eplivanserin on day 1.

    Serious adverse events
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.07 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years Eplivanserin 0.07 mg/kg: 12-17 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Eplivanserin 0.01 mg/kg: 6-11 years Eplivanserin 0.035 mg/kg: 6-11 years Eplivanserin 0.07 mg/kg: 6-11 years Eplivanserin 0.01 mg/kg: 12-17 years Eplivanserin 0.035 mg/kg: 12-17 years Eplivanserin 0.07 mg/kg: 12-17 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 7 (42.86%)
    1 / 7 (14.29%)
    3 / 7 (42.86%)
    2 / 7 (28.57%)
    4 / 7 (57.14%)
    3 / 6 (50.00%)
    Injury, poisoning and procedural complications
    Accidental overdose
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Excoriation
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Animal bite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Skin laceration
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Head injury
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Cardiac disorders
    Sinus tachycardia
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Hiccups
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Nervous system disorders
    Somnolence
         subjects affected / exposed
    2 / 7 (28.57%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    1
    1
    0
    0
    Lethargy
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    2 / 7 (28.57%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    1
    2
    1
    Eye disorders
    Lacrimation increased
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Ear and labyrinth disorders
    Tinnitus
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Fatigue
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    1
    2
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Photosensitivity reaction
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    2
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    Infections and infestations
    Tooth abscess
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Lymphadenitis viral
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    0 / 7 (0.00%)
    1 / 7 (14.29%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Jun 2009
    It included following statements: Change in pharmacokinetic sampling to ensure optimal conditions to measure eplivanserin and SR141342 half-lives, change in exclusion criteria (reinforced exclusion of illicit drugs), additional ECG measurement (Superimposed median) that was more appropriate for pediatric subjects, change in destination of pharmacokinetic specimen collection shipments and clerical changes for greater understanding.
    14 Sep 2009
    It included following points: Subjects taking CYP2B6 inhibitors and CYP3A4 inducers as concomitant drugs should be excluded and also subjects with abnormal hepatic function (eg, alkaline phosphatase > Upper Limit of Normal range [ULN], total bilirubin > ULN [except in Gillberts Syndrome], Alanine aminotransferase [ALT] > ULN).

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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